Kornimate/medical-research-clean huggingface dataset:
primary versus secondary metal stent implantation in ptbd

Conditions: Bile Duct Obstruction; Extrahepatic Cholestasis

Summary: the aim is to compare percutaneous transhepatic biliary drainage (ptbd) with primary metal stent implantation (one stage-procedure) with ptbd with secondary metal stent implantation in terms of adverse events.

percutaneous transhepatic biliary interventions (pbi) are used in biliary tract diseases when endoscopic access was not successful or not possible due to anatomical changes after abdominal surgery. self-expandible metal stents (sems) can be applied percutaneously in patients with malignant extrahepatic bile duct obstruction. in this setting, ptbd is usually performed as a two step-procedure with primary drainage of the accumulated bile fluid by an external or an external/internal plastic stent and a secondary metal stent implantation at an interval of a few days. ptbd with primary metal stent implantation might shorten the hospital stay and is therefore equal to the increasingly used method of endoscopic ultrasound-guided biliary drainage (eus-bd). eus-bd offers a one step-procedure with primary metal stent implantation which is probably associated with lesser adverse events (ae) than ptbd with secondary metal stent implantation. however, it is not clear whether ptbd with primary metal stent implantation shows fewer adverse events than ptbd with secondary stent implantation. the aim of this study is to retrospectively analyze the prospectively collected data of ptbds with primary or secondary metal stent implantation in patients with proximal and distal malignant bile duct obstruction. the focus of this single center study will be to compare the two approaches in terms of adverse events. adverse events in ptbd might range from very mild to fatal. therefore, the severity of the adverse events has been considered in the calculation.

Eligibility criteria:
inclusion criteria: * ptbd with metal stent implantation into the extrahepatic bile duct * malignant and non-resectable extrahepatic bile duct obstruction exclusion criteria: * benign extrahepatic bile duct obstruction

Keywords: bile duct obstruction self expandable metallic stents
phase ii clinical trial: multi-dosing the bcg vaccine for fibromyalgia

Conditions: Fibromyalgia

Summary: the investigators are doing this research study to explore whether the bacillus calmette-guérin (bcg) vaccine can be an effective treatment for fibromyalgia. the researchers believe that the bcg vaccine can benefit people with fibromyalgia by increasing immune signaling molecules, called cytokines. the faustman immunobiology laboratory has previously studied bcg in long term type 1 diabetics, and found that bcg vaccinations showed a short and small pancreas effect of restored insulin secretion. eligible volunteers will be vaccinated with bcg in repeat fashion over a period of three years or receive placebo treatment. the investigators hypothesize that these repeat injections of bcg will reduce symptom severity by increasing immune signaling cytokines.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia * hiv antibody negative * normal complete blood count (cbc), lft, metabolic panel * meets the requirements for pain measured by the widespread pain index and symptom severity scale * negative pregnancy test within 7 days before initiation of study drug (female only) exclusion criteria: * history of hiv or hepatitis * history of tuberculosis, mycobacterium exposure, tb risk factors, positive interferon-gamma release assay (igra, also known as t-spot.tb test) or bcg vaccination * current treatment with glucocorticoids or disease likely to require steroid therapy * conditions or treatments associated with risk of infections such as patients with a previous history of severe burns, or treatment with immunosuppressive medications of any type * daily use of aspirin \> 160 mg, or chronic, daily nsaids * current treatment with antibiotics * history of keloid formation * severe pain due to other conditions * current treatment with any type ii diabetes medication (such as metformin, farxiga, etc.) * pregnant or not using acceptable birth control * living with someone who is immunosuppressed and/or at high risk for infectious diseases

Keywords: fibromyalgia
preserve-zenith® iliac branch system clinical extended study

Conditions: Aorto-iliac Aneurysms; Iliac Aneurysms

Summary: the preserve-zenith® iliac branch system clinical study is a clinical trial to collect confirmatory safety and effectiveness data on the zenith® branch endovascular graft-iliac bifurcation system. this system is made up of two devices: the zenith® branch endovascular graft-iliac bifurcation and the connectsx™ covered stent in the treatment of aorto-iliac and iliac aneurysms


Eligibility criteria:
inclusion criteria: * an aortioiliac or iliac aneurysm * an unsuitable distal sealing site for a traditional zenith iliac leg graft within the common lilac artery exclusion criteria: * less than 18 years of age * inability or refusal to give informed consent * disease considerations that would compromise patient safety or study outcomes * unsuitable arterial anatomy

Keywords: zenith aortoiliac aneurysm iliac aneurysm branch connections endovascular graft graft-iliac bifurcation aneurysm vascular diseases cardiovascular diseases
internet-cbt for parkinsons disease

Conditions: Parkinson Disease

Summary: the aim of the study is to investigate if an internet-based psychological treatment based on principles from cognitive behavioral therapy can increase function and quality of life for patients with parkinson disease.

the internet-based cognitive behavioral therapy (icbt) will be given as an adjunct to the standard medical treatment. icbt will be compared to standard medical treatment alone (smt). a secondary aim is make a preliminary evaluation of the icbt-program with less and less active therapist support. it is hypothesized that both active treatments will be superior to smt in improving quality of life and functioning and that icbt with full therapist support will be superior to icbt with lower level of therapist support.

Eligibility criteria:
inclusion criteria: * diagnosed parkinson disease * wsas score of over 17 * access to a internet connected device and a mobile phone capable of receiving sms exclusion criteria: * substance or alcohol abuse * psychotic disorder or bipolar disorder * other psychiatric disorder that requires immediate attention or hinders the offered icbt treatment * practical obstacles such as difficulties using the technology required to participate in the study, not having the time to actively wok with the treatment, or having symptoms from parkinson to severe to be able to actively participate in the study * high suicide risk, defined as: * 5 or 6 points on the question about suicidal thoughts on the montgomery-asberg depression scale (madrs) * a standardized clinical interview on suicidal thoughts if the score on the above question is 4

Keywords: internet treatment cognitive behavioral therapy level of functioning quality of life
the "global paradise system" registry

Conditions: Hypertension

Summary: the gps registry is a multi-centre, single-arm, non-interventional (observational) registry. in addition to collecting data from patients treated as per standard clinical practice, the registry will also regularly collect telemetric home blood pressure (hbp) measurements and patient reported outcome (pro) data via a standardized quality of life questionnaire. the objective of the gps registry is to document the long-term safety and effectiveness of the commercially available paradise ultrasound renal denervation system when used per its labelling in patients deemed to be candidates for rdn as per physician's assessment.


Eligibility criteria:
inclusion criteria: * appropriately signed and dated informed consent * age ≥18 at time of consent * patient candidate for renal denervation with the paradise system based on physician's assessment or patient treated with the paradise ultrasound renal denervation system within the 6 months prior to consent exclusion criteria: patients who meet any of the contraindications listed in the instructions for use will be excluded. the contraindications are: * stented renal artery * less than 18 years of age * pregnant * known allergy to contrast medium * renal arteries diameter \ 8 mm * renal artery with fibromuscular (fmd) disease * renal artery aneurysm * renal artery stenosis of any origin \>30% * iliac/femoral artery stenosis precluding insertion of the paradise catheter

Keywords: hypertension blood pressure renal denervation
investigation of the effectiveness of visual feedback training on upper extremity functions in cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of the study was to investigate the effectiveness of cogniboard® light trainer, an education device with visual feedback that is added to the neurodevelopmental therapy method (ndt) based upper extremity rehabilitation in children with cerebral palsy, on upper extremity functions such as joint range of motion (rom), muscle tone, grip strength, pinch strength and functional abilities.

children with the diagnosis of cerebral palsy, aged between 4 and 18 years were included in the study, who were volunteered to participate. the participants were randomly assigned into two groups; a total of 16 sessions of rehabilitation program were applied for 2 days a week for 8 weeks. the treatment programs applied are; group i: ndt based upper extremity rehabilitation, group ii: ndt based upper extremity rehabilitation + cogniboard® light trainer training. in the cases, pre- and post-treatment spasticity was defined with 'modified ashworth scale'; upper extremity joint range of motion (rom) with 'goniometer'; grip and pinch strength with 'dynamometer'; hand skills with 'minnesota hand skill test'; functional abilities with 'childhood health assessment questionnaire (chaq) and functional level with 'gross motor function classification system (gmfcs)'.

Eligibility criteria:
inclusion criteria: * having the diagnosis of cerebral palsy (cp), * aged between 4-18, * having 1+ upper extremity spasticity at max according to the modified ashworth scale (mas), * to be able to cooperate with exercises exclusion criteria: * having mental retardation report, * having congenital deformities, * epilepsy history, * having cardiac, orthopedic, visual and hearing problems, * application of botulinum toxin (botox) to the upper extremity in past six month.

Keywords: cerebral palsy upper extremity rehabilitation neurodevelopmental therapy physiotherapy and rehabilitation visual feedback device
study of techniques of subcutaneous administration of fluids enabled by human recombinant hyaluronidase

Conditions: Dehydration

Summary: the purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of lactated ringer's (lr) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. the safety and tolerability of hylenex-augmented sc infusion of lr through these delivery systems is also being evaluated.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 60 years * intact normal skin without potentially obscuring features on both anterior thighs in the area intended for infusion * agreeing to no fluid intake for 12 hours prior to start of study infusion * vital signs within normal range or, if outside normal range, deemed not clinically significant * metabolic panel, hematology, virology and standard 10-test urine dipstick tests within normal range, or if outside normal range, deemed not clinically significant * if female of child-bearing potential,negative serum pregnancy tests * negative urine drug screens * written informed consent for participation exclusion criteria: * lower extremity edema * lower extremity pathology that could interfere with study outcome * history of cardiovascular disease * rales on lung auscultation * known allergy to hyaluronidase or other ingredient in the formulation of hylenex * pregnancy or breast-feeding a child * exposure to any experimental drug within 30 days prior to study participation * previous participation in this study

Keywords: dehydration fluid therapy hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis subcutaneous hydration subcutaneous rehydration hyaluronan rhuph20
characterising arm recovery in people with severe stroke

Conditions: Stroke

Summary: the main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. the investigators will determine 'who recovers', 'who does not recover', and 'why'

the main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. the prevalence and severity of stroke related arm disability is increasing and the prospect of optimal recovery is poor. studies have demonstrated that stroke survivors with severe disability lack early indicators (\<7-days to \<1-month post-stroke) of a good prognosis, such as active movement at the shoulder and wrist and integrity of the corticospinal tract. this has propagated the clinical belief that this cohort are unlikely to functionally benefit from rehabilitation efforts. however, it is possible that indicators of potential for recovery - either neuroanatomical or clinical - may present in individuals with severe stroke later, that is beyond the early time-period. indeed, there is increasing evidence of the potential for ongoing improvements in motor performance in response to intensive interventions that are undertaken 6-months or more post-stroke. this therefore, implies that there is some degree of untapped recovery potential. however, as very few studies have longitudinally explored the potential indicators of recovery in a severe cohort, the dynamic capacity of the severely damaged remains unknown. thus, there is a need to determine 'who recovers', 'who does not recover', and 'why' to be able to promote optimal arm recovery in people with severe impairment after stroke. we will assess stroke survivors \<4-weeks, 3-months, 6-months and 12-months post stroke using a range of neuroimaging and clinical outcome measures. the findings from this study will build the foundations for more personalized health care options for people with severe arm impairment post stroke.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 90 years; * sustained their first stroke; * demonstrate subacute (\<1 month) and severe upper limb motor deficits (defined by a safe \[shoulder abduction and finger extension\] score of \<5 out of 10 points); and * can follow single stage commands exclusion criteria: * neurological condition other than stroke e.g., parkinson's disease

Keywords: stroke upper limb neuroplastic change longitudinal function
the effect of bone mineral density in patients with adult cystic fibrosis

Conditions: Cystic Fibrosis; Postural Defect; Pulmonary Disease; Physical Inactivity

Summary: the study was conducted in the age range of 18-45 december, who were diagnosed with cystic fibrosis.

60 voluntary patients who have signed the consent form will be included. within the scope of the research the demographic information of the individuals will be recorded. functional capacities of individuals with the shuttle walking test at increasing speed, respiratory functions respiratory function test, with measurements of respiratory november muscle strength and endurance, the level of dyspnea was modified medical peripheral november muscle strength hand dynamometers with research council (mmrc) dyspnea scale posture assessment with the corbin posture analysis scale, trunk mobility with the trunk pelvis-hip angle test, core stabilization with sahrmann's core stability test, individuals' perception of cosmetic deformity walter reed visual assessment questionnaires

Eligibility criteria:
inclusion criteria: * patients aged between 18-45 who were diagnosed with cystic fibrosis exclusion criteria: in the last year, patients; * who had a fracture in any part of the patient's body * who had undergone spine surgery * who had an orthopedic, neurological or metastatic history in addition to cystic fibrosis
acetic acid colonoscopy enhancement study

Conditions: Colorectal Cancer; Serrated Adenomas; Colon Nos Polypectomy Tubular Adenoma

Summary: the purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy. patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. each enrolled subject will undergo two "back-to-back" procedures limited to the examination of the right colon. subjects in group a (study group) will undergo a standard colonoscopy. once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. subjects in group b (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time. results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for serrated lesions. secondary outcome measures will include adenoma detection rate in the right colon or other locations, characteristics of polyps detected, including size and histological results. subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected adverse events. clinical results will be analyzed using various statistical measures of significance.


Eligibility criteria:
inclusion criteria: 1. the patient is \>40 years old 2. the patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; 3. the patient must understand and provide written consent for the procedure. exclusion criteria: 1. patients with a history of colonic resection; 2. patients with inflammatory bowel disease; 3. patients with a personal history of polyposis syndrome; 4. patients with suspected chronic stricture potentially precluding complete colonoscopy; 5. patients with diverticulitis or toxic megacolon; 6. patients with a history of radiation therapy to abdomen or pelvis; 7. patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Keywords: colorectal cancer serrated adenomas screening adenoma detection rate polypectomy
investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of multiple dosing of nnc0174-0833 in subjects with obesity or overweight

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in the united states of america. the aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple dosing of nnc0174-0833 in subjects with obesity or overweight.


Eligibility criteria:
inclusion criteria: * male or female of non-childbearing potential (ncbp), aged 22-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. overweight should be due to excess of adipose tissue, as judged by the investigator exclusion criteria: * history or presence of any clinically relevant respiratory, metabolic, renal, hepatic,gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or other major disorders including sleep apnoea or excessive sleepiness that might require medical attention * history or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, and heart failure * history or presence of a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. paget´s disease, osteoporosis) * male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) of childbearing potential (pearl index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical product
safety and acceptability study of prepex device when removing the foreskin shortly after placement of device

Conditions: HIV Prevention

Summary: to assess the safety and acceptability of the non-surgical prepex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.

to assess the safety and acceptability of the non-surgical prepex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement. five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the prepex. theses clinicians and nurses have already been trained in the prepex procedure and will undergo further training in the modification to the technique. study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.

Eligibility criteria:
inclusion criteria: * ages - 13 to 49 years * uncircumcised * participant wants to be circumcised * participant assent to the procedure * legal guardian consent to the procedure for ages 13-18 years * able to understand the study procedures and requirements * agrees to abstain from sexual intercourse for 8 weeks after circumcision * agrees to abstain from masturbation for at least 2 weeks after removal * agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total) * participant able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study exclusion criteria: * legal guardian withholds consent for ages 13-18 years * active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision * participant with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias * known bleeding / coagulation abnormality, uncontrolled diabetes * participant that to the opinion of the investigator is not a good candidate * diabetes mellitus * hiv sero-positive